Boscolo-Berto Rafael, Montisci Massimo, Secco Silvia, D'Elia Carolina, Snenghi Rosella, Viel Guido, Ferrara Santo Davide
Department of Cardiac, Thoracic and Vascular Sciences, Section of Legal Medicine, University Hospital of Padova, Via Falloppio 50, Padova, 35121, Italy.
Department of Urology, Ospedale Niguarda Cà Granda, Piazza Ospedale Maggiore 3, Milano, 20162, Italy.
J Bioeth Inq. 2016 Sep;13(3):439-48. doi: 10.1007/s11673-016-9732-2. Epub 2016 Jul 14.
A conflict of interest (COI) is a situation in which a person has competing loyalties or interests that make it difficult to fulfil his or her duties impartially. Conflict of interest is not categorically improper in itself but requires proper management. A SCOPUS literature search was performed for publications on the efficacy/safety of Phospho-Di-Esterase Inhibitors (PDEIs) for treating erectile dysfunction. A categorization tool (CoOpCaT) was used to review and classify the publications as supportive/not-supportive for the discussed active ingredient and reporting or not reporting a COI for that specific drug or for the remaining PDEIs (i.e. competitors). Multivariable binary logistic regression was performed. In the 419 selected records the prevalence of supportive opinions was higher when a COI for the index label was declared. The CoOpCaT showed good internal consistency, discriminative validity and intra/inter-rater agreement. The strongest predictor for a supportive opinion was the total number of financial COIs for the index label. A mild protective effect of the total number of financial COIs for any competitor label was noted. Financial COIs have frequently been associated with bias, and the measures currently adopted to restrain it lack effectiveness. Some evidence for monitoring and/or compensating this bias is reported here, but the ultimate solution remains distant.
利益冲突(COI)是指一个人存在相互竞争的忠诚或利益,使其难以公正履行职责的情况。利益冲突本身并非绝对不当,但需要妥善管理。我们对Scopus文献进行检索,查找关于磷酸二酯酶抑制剂(PDEIs)治疗勃起功能障碍的疗效/安全性的出版物。使用一种分类工具(CoOpCaT)对这些出版物进行审查和分类,判断其对所讨论的活性成分是支持还是不支持,以及是否报告了针对该特定药物或其余PDEIs(即竞争对手)的利益冲突。进行了多变量二元逻辑回归分析。在419条选定记录中,当声明索引标签存在利益冲突时,支持性意见的比例更高。CoOpCaT显示出良好的内部一致性、区分效度以及评分者间/评分者内一致性。支持性意见的最强预测因素是索引标签的财务利益冲突总数。注意到任何竞争标签的财务利益冲突总数有轻微的保护作用。财务利益冲突常常与偏倚相关,目前用于抑制偏倚的措施缺乏有效性。本文报告了一些监测和/或补偿这种偏倚的证据,但最终解决方案仍遥不可及。